Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002710220

FEI Number

3002710220

Entity Name

TECAN AUSTRIA GMBH

City/State/Country

GROEDIG Salzburg, AT

Establishment Address

1A UNTERSBERGSTRASSE, GROEDIG Salzburg 5082, AT

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tecan Group AG (Owner Number: 9050992)

Owner / Operator Contact Address

103 Seestrasse, --, Maennedorf, CH-ZH 8708, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HYDROFLEX PLUS HYDROFLEX HYDROFLEX EVOLYZER 8CH HYDROFLEX EVOLYZER 16CH HYDROFLEX ELISA HYDROSPEED HYDROFLEX FREEDOM EVO 96PW PW384 COLUMBUS INFINITE F500 INFINITE M1000 INFINITE 200 PRO - INFINITE F Plex INFINITE 200 PRO - INFINITE Lumi INFINITE 200 PRO - INFINITE M Nano INFINITE 200 PRO - INFINITE M Nano+ INFINITE 200 PRO - INFINITE M Plex INFINITE 200 PRO - INFINITE F Nano+ INFINITE M1000 PRO INFINITE 200 PRO INFINITE 200 INFINITE F200 MICROPLATE FLUORESCENCE READER Magellan Pro Magellan Basic Magellan Pro Standard Magellan Pro Tracker Magellan Tracker Magellan Standard PROFI BLOT 48-2in1 PROFI BLOT T48 PROFI BLOT 48 INFINITE 200 PRO - INFINITE F Nano+ INFINITE 200 PRO - INFINITE Lumi INFINITE 200 PRO - INFINITE M Nano INFINITE 200 PRO - INFINITE M Plex INFINITE 200 PRO - INFINITE F Plex INFINITE 200 PRO - INFINITE M Nano+ INFINITE F50 PLUS INFINITE M1000 INFINITE F500 INFINITE 200 INFINITE F50 ROBOTIC INFINITE F50 SUNRISE INFINITE M1000 PRO SUNRISE-RC/6F ENFER SUNRISE-RC/ST TC CRE SUNRISE-RC/TW EVOLYZER SUNRISE-RC/ST GL.ABBOTT INFINITE F50 ROBOTIC FS SUNRISE-RC/6F EVOLYZER SUNRISE-RC/ST RMP INFINITE 200 PRO SUNRISE-RC/ST EVOLYZER SUNRISE BF SUNRISE-RC/ST GENALYSER SUNRISE-RC/ST ML PR4100 SUNRISE BF V2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2005-02-23
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2002-04-30
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2005-02-23
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2005-02-23
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2007-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

Taunya Alexander Business: Tecan U.S. Email: regulatory.affairs.us@tecan.net Phone: (919) 5725421

Related Public Records

Same Entity

Tecan Group AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010160459	Tecan Software Competence Center GmbH	Mainz-Kastel Rhineland-Palatinate, DE
3003559191	Tecan Trading AG	Maennedorf Zurich, CH
3003402518	TECAN SCHWEIZ AG	MAENNEDORF ZUERICH Zurich, CH
9710337	IBL INTERNATIONAL GMBH	HAMBURG, DE
3003537036	TECAN CDMO SOLUTIONS MH, CORP.	MORGAN HILL, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002710220. Last updated year: 2026. Please use registration number 3002710220 when referencing this establishment in official correspondence.